Abstract
In Germany, the G-BA decides on the added benefit of pharmaceuticals. This rating is the most important factor for the subsequent price negotiations. The G-BA’s rules of procedure (chapter 5 sect. 14 VerfO) allow manufacturers to request a re-assessment based on “new scientific evidence”, which – if accepted – would consequently lead to a re-negotiation as well. This precedence analysis aims at identifying the evidence level required for a re-assessment in general, for an improved benefit rating and ultimately the impact regarding the negotiations with the GKV-SV.
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